cGARD

As part of an ISPE international initiative regarding a guideline on implementing Global Information Systems a team was created to look into, amongst other things, the regulations that needed to be adhered to, when implementing a Global System that could be used as part of a global companies compliance strategy.

Once these regulations had been located, (not an easy task, as they were not readily available), they were reviewed and the group came up with a list of 27 topics, key words, or functions that they thought should be given more consideration with respect to global regulations.

A spread sheet was created to list regulations from many countries, that were found, regarding Global Information Systems (initially) and these were categorised into the following 27 categories:

Audit Trail, Backup and Recovery, Change Management, Configuration Management, Data Privacy, Deviations / Corrective Actions, Disaster Recovery, Document Management

Electronic Signatures, Facilities, Financial, Incident Reporting, Management Responsibilities, Performance Monitoring, Personnel Qualifications / Training / Availability, Protection

Quality Management, Raw Data / Source Data, Record Retention / Archiving, Regulatory Audit, Risk Based Compliance, Security Management, Signatures, Supplier / Vendor Auditing

System Retirement, Testing, Validation Lifecycle

Once it became apparent that the management of this huge spread sheet was not possible Compliance Control Ltd. put this into a simple database, and thus cGARD was created.

Initially starting as a Computer System Validation tool, the database has now grown to contain over 22,000 records, and covers a wide range of regulations and countries, to include Manufacturing, Laboratory, Clinical, and Distribution regulations, as well as many other.

This online regulatory compliance service and software tool brings together precise up-to-date, categorised regulatory information. It's ability to search Regulations and provide assessment reports, along with accessing and searching  FDA Warning Letters and access latest industry news assists companies in effectively co-ordinating their corporate regulatory intelligence requirements and stay inspection ready.

Currently, ComplianceControl cGARD contains regulations from the US, EU/EC, UK, Canada China, Poland and Japan including all International standards from ICH and relevant International Regulations from OECD. There are many other applicable regulations and industry guidance issues that can also be incorporated in future versions on request.

                                                    

A complete chronological log of the regulations that have been included in cGARD History Page.



     
     

Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 




© Compliance Control 2014